Efficacy Study of Adalimumab to Treat Interstitial Cystitis
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ClinicalTrials.gov Identifier: NCT01295814 |
Recruitment Status :
Completed
First Posted : February 15, 2011
Results First Posted : July 16, 2015
Last Update Posted : July 16, 2015
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The purpose of this study is to evaluate an investigational treatment for interstitial cystitis. Interstitial cystitis is a chronic bladder disease that includes the following symptoms: Urinary frequency during the day,urinary frequency at night, urinary urgency and bladder discomfort relieved by voiding.
Presently, there is no cure for interstitial cystitis. The response to current treatments is poor. Patients with interstitial cystitis have a poorer quality of life. The cause of interstitial cystitis is unknown. This study is evaluating the drug Humira® (adalimumab) for improving the symptoms of patients with interstitial cystitis. Humira® is an injectable anti-inflammatory medication that has been available for use since December 31, 2002. Humira® has been FDA approved for the treatment of rheumatoid arthritis, psoriasis, ankylosing spondylitis, and Crohn's disease. These diseases have similar characteristics to interstitial cystitis. This study will evaluate an investigational use of Humira® for the treatment of interstitial cystitis.
Condition or disease | Intervention/treatment | Phase |
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Interstitial Cystitis | Drug: Adalimumab Other: inactive drug | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 43 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | An Investigator Initiated, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Humira® (Adalimumab) For The Treatment of Interstitial Cystitis(IC) |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | July 2013 |

Arm | Intervention/treatment |
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Experimental: adalimumab
Adalimumab 80mg subcutaneous loading dose followed by 40 mg subcutaneous every 2 weeks for 12 weeks
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Drug: Adalimumab
80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
Other Name: Humira |
Placebo Comparator: Inactive drug
Placebo in identical syringe subcutaneous every 2 weeks for 12 weeks
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Other: inactive drug
80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
Other Name: placebo |
- O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score [ Time Frame: Baseline/12 Weeks ]Improvement in the O'Leary Sant Symptom and Problem Index from baseline to week 12 Total scores on a scale range: 0-36 (0, meaning no symptoms to 36, meaning the most severe symptoms)
- Interstitial Cystitis Symptom Index (ICSI) [ Time Frame: Baseline/ 12 weeks ]Improvement in O'Leary Sant Interstitial Cystitis Symptom Index (ICSI) Total scores on a range scale: 0-20 (0, meaning no symptoms, to 20, meaning the most severe symptoms)
- Interstitial Cystitis Problem Index (ICPI) [ Time Frame: Baseline/12 Weeks ]Improvement in O'Leary Sant Interstitial Cystitis Problem Index (ICPI) Total scores on a scale: 0-16 (0, meaning no symptoms, to 16, meaning the most severe symptoms)
- Pelvic Pain Urgency/Frequency (PUF) Score [ Time Frame: Baseline12 Weeks ]Pelvic Pain, Urgency/Frequency Symptom Scale Total scores on a scale range: 0-35 (0, meaning no symptoms, to 35, meaning the most severe symptoms)
- Global Response Assessment (GRA) [ Time Frame: Measured at12 Weeks ]
Percent(%) of patients who reported 50% or greater overall improvement in their condition.
Score on a scale range (improvement 0%-100%)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males or females ≥18 and ≤ 65 years of age previously diagnosed with Interstitial Cystitis
- Currently have symptoms of urinary urgency, frequency or pain for more than 6 months
- Urinating at least 7 times a day or having some urgency or pain (measured on linear analog scales)
- Must be post-menopausal or surgically sterile or willing to use an adequate form of birth control
- Not pregnant or lactating
- Capable of voiding independently
- Willing to provide informed consent to participate
Exclusion Criteria:
- Have symptoms that are presently relieved on other medications for interstitial cystitis
- Have absence of nocturia
- Have symptoms that are relieved by antimicrobials or antibiotics.
- Have a body mass index (BMI) of >39 kg/m2
- Have uncontrolled hypertension
- Have Type I or type 2 diabetes
- Have active Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) infection, or who are known carriers (Hepatitis B) at Screening
- Have a positive tuberculosis test at screening
- Have had a urinary tract infection for 6 weeks
- Have had bacterial cystitis in previous 3 months
- Have had previous exposure to Humira® (adalimumab)
- Have taken investigational medication within 30 days of screening
- Have any other condition/disease which, in the opinion of the investigator, could compromise subject safety or confound the interpretation of study results
- Are unable or unwilling to comply with protocol requirements

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295814
United States, California | |
Philip C. Bosch, MD | |
Escondido, California, United States, 92025 |
Principal Investigator: | Philip C Bosch, MD |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Philip C. Bosch, M.D., Urologist, ICStudy, LLC |
ClinicalTrials.gov Identifier: | NCT01295814 |
Other Study ID Numbers: |
IMM 10-0061 |
First Posted: | February 15, 2011 Key Record Dates |
Results First Posted: | July 16, 2015 |
Last Update Posted: | July 16, 2015 |
Last Verified: | July 2015 |
Interstitial cystitis Humira Adalimumab |
Cystitis Cystitis, Interstitial Urinary Bladder Diseases Urologic Diseases |
Adalimumab Anti-Inflammatory Agents Antirheumatic Agents |